Device product
Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid.
Z-0311-2018
Product summary
- Event
- Event 78833
- Status
- Terminated
- Classification
- Class II
- Quantity
- 412
- Official record key
device-enforcement:Z-0311-2018
Official wording
Reason: If the lock mechanism of the movable camp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is applied. This may happen when the detector is rotated clockwise from landscape to portrait position.
Code information: 9890-010-88152 - Codes included in attached list. Devices were manufactured and distributed from March 2015 - March 2017.
Distribution pattern: 412 units affected.
Derived failure modes
-
Unknown
If the lock mechanism of the movable camp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is applied. This may happen when the detector is rotated clockwise from landscape to portrait position.